US 11,986,523 B2
Stable liquid formula comprising anti-TNFa antibody, acetate buffer, and glycine
Joon Won Lee, Incheon (KR); Yeon Kyeong Shin, Incheon (KR); Hye Young Kang, Incheon (KR); Kwang Woo Kim, Incheon (KR); So Young Kim, Incheon (KR); Su Jung Kim, Incheon (KR); Jun Seok Oh, Incheon (KR); and Won Yong Han, Incheon (KR)
Assigned to CELLTRION INC., Incheon (KR)
Filed by CELLTRION INC., Incheon (KR)
Filed on Mar. 16, 2021, as Appl. No. 17/202,982.
Application 17/202,982 is a continuation of application No. 16/477,187, granted, now 10,980,881, previously published as PCT/KR2018/000493, filed on Jan. 10, 2018.
Claims priority of application No. 10-2017-0004345 (KR), filed on Jan. 11, 2017.
Prior Publication US 2021/0205454 A1, Jul. 8, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); A61K 9/08 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01); C07K 16/00 (2006.01); A61K 47/26 (2006.01); C07K 14/525 (2006.01); C07K 16/24 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/08 (2013.01); A61K 39/3955 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); C07K 16/00 (2013.01); A61K 47/26 (2013.01); C07K 14/525 (2013.01); C07K 16/241 (2013.01)] 14 Claims
 
1. A liquid formulation, comprising:
(A) an antibody or antigen-binding portion thereof, (B) an acetate buffer, (C) glycine and (D) a surfactant,
wherein:
the antibody has a concentration of 50 to 150 mg/mL,
the glycine has a concentration of 210 to 300 mM,
the liquid formulation has an osmolality ranging from 200 to 400 mmol/kg, and
the liquid formulation does not comprise sucrose nor trehalose nor mannitol nor sorbitol nor NaCl.